Truth or Dare; Artificial Blastocoel Collapse Using Laser Before Blastocyst's Vitrification Versus Non-laser Usage

NCT04124809 | Terminated DMC

• 1 other identifier: Hawaa-7
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

: This prospective randomized observational study aimed to compare behavior of artificially collapsed blastocysts to blastocysts that were vitrified without artificial collapse.

Conditions

Blastocyst Disintegration

Keywords

blastocyst; Vitrification; artificial collapse; survival rate

Outcome Measures

Primary Outcomes (2)

• survival rate

  survival rate will be assessed immediately after thawing and compared between both groups.

  immediately after thawing

• survival rate

  survival rate will be assessed at 140 minutes after thawing and compared between both groups.

  140 min after thawing

Study Arms (2)

Study group (artificially laser-collapsed blastocysts)

EXPERIMENTAL

laser was used as an intervention before blastocyst vitrification to assist rapid blastocyst collapse with vitrification

Device: laser assisted collapse

& control group (blastocysts were vitrified, no laser collapse

NO INTERVENTION

blastocyst were vitrified without laser assisted collapse

Interventions

laser assisted collapse DEVICE

Apply 1-2 pulses of laser using the Saturn between 2 adjacent trophectoderm cells away from the inner cell mass in the blastocysts

Study group (artificially laser-collapsed blastocysts)

Eligibility Criteria

• Age: 20 Years - 37 Years
• Gender Eligibility Details: blastocysts of infertile couples
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age limit 20-37 At least 6 good quality blastocysts per case. expansion rate 3-4

You may not qualify if:

• bad quality blastocysts expansion rate less than 3

Sponsors & Collaborators

• Benha University: lead
• Hawaa Fertility Center: collaborator

Study Sites (1)

Hawaa Fertility Center

Banhā, Qalyubia Governorate, 13512, Egypt

Location

MeSH Terms

Conditions

Embryo Loss

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• sahar A Eissa, Ph. D

  HFC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: only the investigator knew the procedure provided for each case
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Obstetrics & Gynecology

Model Details: patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) \& control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately \& at 140 min after thawing and compared between two groups.

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 11, 2019
• Study Start: January 5, 2019
• Primary Completion: September 15, 2021
• Study Completion: October 1, 2021
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of the study , for 6 months
• Access Criteria: saharafify @yahoo.com

Locations

EG (1)